Tuesday, 22 September 2020

Novadoz /MSN Labs get FDA approval of generic Febuxostat tablets

01 January 2020 | News

Febuxostat brand and generic sales are trending over $430MIL over the previous 12 months according to recent published sales data

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.  The product is AB rated to the brand Uloric©, marketed by Takeda Pharmaceuticals America, Inc.  The company has commenced shipping of the product that is available in bottles of 30 tablets. Febuxostat brand and generic sales are trending over $430MIL over the previous 12 months according to recent published sales data.

Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia (elevated levels of uric acid) in adult patients with gout who have a poor response to a maximally titrated dose of Allopurinol, patients intolerant to Allopurinol, and for treatment where Allopurinol is not advisable.

Seshu Akula, Novadoz President North America Generics, states, "FDA approval of Febuxostat is the 12th product introduction for the Novadoz label in the first 20 months of our U.S commercialization.  Novadoz and the MSN organizations are committed to being part of DAY 1 and DAY 181 product launches, providing high value to our customers, and to the pharmacies and companies in their supply chain. Our vertical integration through MSN, the #1 API supplier in the world, continues to define our success now and in the future.  We expect continued success in 2020 with multiple product approvals, including several in the specialty oncology space."

Tom DeStefano, Novadoz Vice President Sales & Marketing quotes, "2019 had many successes in our first full year of operation.  We have gratitude for the customers that placed confidence in our ability to supply high volume, and specialty products.  Our successful supply chain management ensures customers on-time order fulfillment.  The FDA approval of Febuxostat furthers our emergence as a future leader in the generic pharma industry."  

MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates.  MSN is the global leader in this category. Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S as Novadoz Pharmaceuticals.

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